Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

Completed

• Conditions: Endometriosis; Endometrioma; Surgery
• Interventions: Other: Anti-mullerian hormone (AMH) level dosage.; Other: Follicle-stimulating hormone (FSH) level dosage.; Other: Antral follicle count (AFC).

• Registration Number: NCT02047838
• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Brief Summary

This retrospective case-control study was performed in an Academic centre for the diagnosis and treatment of endometriosis. It included patients with recurrent unilateral endometriomas who were previously operated for the same condition (cases) and patients without recurrency who previously underwent surgery for unilateral endometrioma (controls). The primary outcome of the study was to assess the impact on ovarian reserve of second surgery for recurrent unilateral endometriomas. The evaluation of ovarian reserve was performed by assessing serum anti-mullerian hormone (AMH) level, serum follicle-stimulating hormone (FSH) level, 17-beta estradiol level and antral follicle count (AFC).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-01-25
• Study First Submitted QC: 2014-01-25
• Study First Posted: 2014-01-28
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-22
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• reproductive age (at the time of both surgical procedures);
• two surgical procedures on the same ovary (stripping of endometrioma with
• largest diameter ≥ 4 cm; cases) performed at our Institution;
• one surgical procedures (stripping of endometrioma with largest diameter ≥ 4 cm; controls) performed at our Institution;
• histological diagnosis of ovarian endometriomas;
• complete assessment of ovarian reserve at routinary follow-up at our institution.

Exclusion Criteria

• patients aged ≥ 40 years at the time of primary surgery;
• surgical procedures on the contralateral ovary (at primary or second-line surgery);
• previous salpingectomy or hysterectomy;
• unilateral ovariectomy at the time of first or second surgery;
• ultrasonographic diagnosis of persistent endometrioma after first surgery;
• additional surgical procedures for endometriomas or for other ovarian diseases before first surgery and between first and second surgery;
• hormonal treatment within 3 months from ovarian reserve assessment;
• patients followed-up < 3 months after second-line surgery (for cases).
• pregnancy and/or breastfeeding during the study period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls.	Anti-mullerian hormone (AMH) level dosage.	Patients previously operated for unilateral endometrioma without recurrence.
Controls.	Follicle-stimulating hormone (FSH) level dosage.	Patients previously operated for unilateral endometrioma without recurrence.
Cases.	Anti-mullerian hormone (AMH) level dosage.	Patients with recurrent unilateral endometrioma who were previously operated for the same condition.
Cases.	Antral follicle count (AFC).	Patients with recurrent unilateral endometrioma who were previously operated for the same condition.
Controls.	Antral follicle count (AFC).	Patients previously operated for unilateral endometrioma without recurrence.
Cases.	Follicle-stimulating hormone (FSH) level dosage.	Patients with recurrent unilateral endometrioma who were previously operated for the same condition.

Primary Outcome Measures

Name	Time	Method
Anti-mullerian hormone (AMH) level.	In cases, anti-mullerian hormone (AMH) level was determined 3 months after second laparoscopic surgery. In controls, AMH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).

Secondary Outcome Measures

Name	Time	Method
Follicle-stimulating hormone (FSH) level.	In cases, follicle-stimulating hormone (FSH) level was determined 3 months after second laparoscopic surgery. In controls, FSH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
Antral follicle count (AFC).	In cases, antral follicle count (AFC) was determined 3 months after second laparoscopic surgery. In controls, antral follicle count was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
17-beta estradiol level.	In cases, 17-beta estradiol level was determined 3 months after second laparoscopic surgery. In controls, 17-beta estradiol level was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro; 🇮🇹 Genoa, Ligury, Italy